Understanding process effects on the stability of amorphous form products (recrystallization of amorphous form products)

了解工艺对非晶态产品稳定性的影响（非晶态产品的再结晶）

• 批准号: 2597396
• 金额: --
• 依托单位: University of Leeds
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-2597396
• 关键词: Understanding; process; effects; stability; amorphous

Aims:The aim of the project is to understand how various processes influence the stability of drug delivery amorphous form products, in order to limit their recrystallisation. These objectives could roughly be divided into three aspects: Characterisation of model drug delivery systems, prepared via two different routes, and stored in a range of conditionsIdentification of the key molecular factors that affect the stability of the model systems (e.g. designing of experiments)Development of more general predictive models and molecular fingerprints.Methodology:Characterisation of the drug delivery systems is the key aspect of the project. Techniques such as electron microscopy and X-ray diffraction will be used to identify nano-sized crystalline regions within the amorphous state that may initiate re-structuring of the material, and thus lead to product instability. This will allow determination of the size, morphology and structure allowing a tempero-spatial assessment of crystalline areas within the sample. Not only is this process time-dependent but is affected by the type of formulation and processes used to generate the amorphous form. Once reliable methods are developed, a correlation with samples that are developed from different production methods can be developed. The project will also look at simulations and models developed from the characterisation, as they can be utilised to predict formulation properties prior to testing. Predictive models with the established data, would be crucial for predicting the crystallisation of active ingredients and drug delivery systems. Potential Impact: The impact of this project will be in areas where an amorphous product is desired, such as with many drugs within medicine. In this instance, if the products are unstable, and crystallise, this may affect the efficacy. In developing methods to identify, then understand and ultimately predict this crystallisation, we will be able to consider the effects of processing and storage conditions.

目的：该项目的目的是了解各种工艺如何影响药物输送非晶态产品的稳定性，以限制其再结晶。这些目标大致可以分为三个方面：表征模型药物传递系统，通过两种不同的途径制备，并在一定条件下存储；确定影响模型系统稳定性的关键分子因素（如实验设计）；开发更通用的预测模型和分子指纹图谱。方法：药物输送系统的特征是该项目的关键方面。电子显微镜和x射线衍射等技术将用于识别非晶状态下的纳米级晶体区域，这些区域可能会引发材料的重新结构，从而导致产品的不稳定性。这将允许确定尺寸，形态和结构，允许样品内结晶区域的温度-空间评估。这一过程不仅与时间有关，而且还受到用于产生非晶态的配方类型和工艺的影响。一旦开发出可靠的方法，就可以开发出与不同生产方法开发的样品之间的相关性。该项目还将着眼于从表征中开发的模拟和模型，因为它们可以在测试之前用于预测配方特性。具有既定数据的预测模型对于预测活性成分和药物传递系统的结晶将是至关重要的。潜在影响：这个项目的影响将在需要非晶产品的领域，例如医药中的许多药物。在这种情况下，如果产品不稳定并且结晶，这可能会影响功效。在开发识别、理解并最终预测这种结晶的方法时，我们将能够考虑加工和储存条件的影响。